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Prior to the actual production, the production chemist assigns the sample
its own unique lot number. At this time, the value of each analyte in the
sample is also assigned by using a random number generator. This is done
by entering the upper and lower end of the analyte's range and letting
it randomly generate a value in between these numbers. Doing so ensures
that the product covers the entire range for each analyte and that values
are not constantly repeated month after month or study after study. As
well, production sheets are created and used by the production chemist
as they make the sample. These sheets are later stored in the product
lot file as a permanent record of how it was made.
When the above items have been completed, the production chemist is
prepared to make the sample. To ensure the best quality, the
balances used for weighing raw materials are calibrated daily
using NIST certified weights and samples are prepared using
Class A volumetric glassware. In addition, APG has two Millipore
Super-Q systems that produce the high purity water that is
used to make our samples. Most importantly, there are written
procedures that reference the exact steps taken to produce
each specific sample type. Every production procedure includes
the mixing of a sample for a minimum of 15 minutes before it
is given to the packaging technicians.
There are many steps that are taken within the packaging department to
ensure that there is no contamination of the samples. Packaging technicians
have written procedures on how each sample type is packaged. Vials,
ampules, and caps are cleaned or washed appropriately according to
their use. Packing records are kept and stored in each product lot
file so that there are no questions on how something was packed. The written
procedures include rinse times to assure clean, uncontaminated tubing
prior to the introduction of the sample. Samples are capped immediately
after being pumped or poured to prevent any further chance for
contamination. Another important step in the packaging of a sample is
the pulling of individual samples that will be used by the QC department
to verify the accuracy of the product and later on the stability of that
same product. These samples are pulled and marked throughout the entire
packaging process for each lot to ensure that the product is the same from the
first sample packed until the last sample is capped.
These samples are then given to the appropriate quality control chemist who
analyzes them to verify their assigned values and consequently the overall
quality of the product. There are written methods for each analysis that
go step by step through the analytical process. In addition, APG uses
third-party verified calibration standards. Furthermore, we use quality
control standards to verify our calibration curves and as a result have
great confidence in our data. After the close date for each study, the
product is analyzed again to verify that it has not significantly changed
since the original analysis. Doing so ensures product accuracy by finding
any instability that may occur. All data from these analyses is entered into
APG's computerized quality control system. This system contains all the
limits and criteria that a product must pass before it is approved for
distribution to our customers. The system significantly reduces any chance
for human error which in turn contributes to APG’s production of high
quality samples. Once a product has met its requirements, it is given to
the shipping department where it is prepared for distribution to customers.
As you can see, the entire focus of APG is to ensure that our customers receive
the high quality samples they deserve. Numerous actions that enable us to achieve
and maintain the required accuracy are taken throughout the whole process. It is
the combination of these things that allow APG to produce the superior quality
samples that meet the needs of our customers.
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